A clinical Phase II Multicentre Study to Investigate Efficacy of Autologous Lymphocytes (ALECSAT) in Patients with Glioblastoma Multiforme Measured as Progression Free Survival Compared to Avastin/Irinoteca
- Conditions
- The overall purpose of the study is to investigate the efficacy and safety of ALECSAT in GBM patients either with relapse of GBM after first line treatments (followed by reoperation if possible). The efficacy and safety of ALECSAT treatment is, compared to standard Avastin/Irinotecan econd line treatments for these patients.MedDRA version: 17.0Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003045-42-DK
- Lead Sponsor
- CytoVac A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
The patients must meet the following criteria in order to be eligible for inclusion in the study:
1.Histologically confirmed GBM tumour with recurrence during or after completing the first-line treatments, documented by MRI
2.Minimum age of 18 years old Capable of understanding the information and giving informed consent
3.Minimum height of 155 cm
1.Expected survival time (life expectancy) of over 3 months
2.Adequate performance status £ 2 (see below*)
3.Clinically normal EVF
4.Women in fertile conditions can only be included with a negative pregnancy test at screening and must use appropriate contraceptives during the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33
Criteria which exclude the patient for entering in the study are:
1.Positive tests for anti-HIV-1/2; HBsAg, anti-HBc, Anti-HCV or being positive in a Treponema Pallidum test (syphilis)
2.Patients which have visit an area where there is an outbreak of West e virus or Dengue virus within 28 days prior to donation should be excluded, unless the patient has been tested negative
3.Concurrent illness, e.g. uncontrolled epilepsy, cardiovascular-, cerebrovascular-, and/or respiratory disease which can worsen or cause complications in connection with blood donation
4.Clinically significant autoimmune disorders or conditions of immune suppression
5.Hemoglobin count = 7.5mmol/l (men & women)
6.Lymphocyte-numbers below 0.5 x 109/l
7.Body weight below 40 kg (men) and 50 kg (women)
8.Clinically abnormal ECG as judged by the Investigator
9.Pregnant or breast feeding women
10.Inclusion in other clinical studies 4 weeks prior to inclusion in the study
11.Any medical condition that will render participation in the study risky or, according to the Investigator will make the assessment of the study endpoints difficult
12.Treatment with any immunotherapy, cytotoxic therapy or, biologic therapy 4 weeks prior to enrolment in this study
13. Patienys that either put a risk due to the blood donation or where it is not expected taht an ALECSAT product of good quality van be produced
14. Patients with uncontrolled serious bacterial, viral , fungal or parasitic infection
15. Blood transfusion within 48 hours prior to donation of blood for LECSAT production
16Known or suspected intolerance to Avastin, Irinotecan or any of the excipients as well as intolerance to recombiant humanized antibodies
17. Performance status >3
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method